Quality Control Analyst

Objective Analyst will perform all QC testing on incoming materials, in-process, finished products and stability studies in a time-sensitive radiopharmaceutical environment.  Support laboratory quality, efficiencies, and improvements, and ensure cGMP compliance.  Acts as Quality Control representative on initiatives, projects, and committees.

Essential Functions Prepares all chemical reagents for product release testing and ensures lab cleanliness and maintain records with consistent cGxP practice.

Provides oversight related to testing incoming materials, in-process and finished products, stability studies and project support.

Performs all QC testing of incoming materials, finished products and stability studies in accordance with SOPs and cGMP guidelines, including :

• Chemistry testing, including instrumental and wet chemistry analyses.
• Routine Environmental Monitoring and utilities testing.
• Sterility, microbial limits and Endotoxin testing, identify and trend microorganisms.
• Provide technical support during equipment commissioning and qualification (IQ / OQ / PQ).
• Coordinate calibration schedules of assets and update the asset management software (BMRAM).
• Ensure proper acceptance of QC materials, maintain and update current QC inventory.
• Provides support to ensure audit readiness of laboratory area.
• Utilize and ensure appropriate staff use of a wide range of electronic systems such as ERP, QMS, EBR, and equipment software.
• Update and maintain Standard Operating Procedures (SOPs, test records and protocols).
• Actively promotes safety rules and awareness.
• Collaborate directly with other departments to achieve completion of projects (Manufacturing, QA, Engineering, RSO, EH&S etc).
• Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and / or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Education / Experience Requires a BA / BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience.
• Minimum of 3 years of experience in the pharmaceutical industry, related GMP environment, or equivalent, performing product testing.
• Experience in a GMP compliant manufacturing following ALCOA+ principle and 21 CFR 211 guidelines is highly preferred.
• Radioactive material handling of gamma, beta and alpha emitters experience preferred.
• Knowledge / Skill / Ability Expertise in analytical techniques required (HPLC, LC-MS, GC, gamma spectroscopy, iTLC, Endotoxin, DAD, Empower 3.0, Open Lab etc.) required.
• Familiar with aseptic technique (clean-room environment) preferred.
• Ability to plan, implement & execute activities to achieve personal and team performance objectives.
• Ability to work independently and in teams.
• Excellent oral and written communication, organization and problem-solving skills Strong interpersonal skills and an understanding of group dynamics.
• Ability to lift / move, transport equipment and materials weighing up to 30 pounds across a frequent basis.
• Flexibility with scheduling requirements may include shifts, overtime, weekends and holiday coverage.
• Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and / or actual exposure levels.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.  Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical / moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities, and activities may change at any time with or without notice.

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